FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,151 results
11041–11064 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 30, 1995
PACIFIC COMMUNICATIONS MODEL 1100
K942147 · DSI
Accucore, Inc.
Cardiovascular · 272d
Cleared Jan 30, 1995
HEWLETT-PACKARD MODEL M1490A WIRELESS PATIENT DATA COMMUNICATOR
K945277 · DXJ
Hewlett-Packard Co.
Cardiovascular · 94d
Cleared Jan 27, 1995
CUFFLINK NON-INVASIVE BLOOD PRESSURE ANALYZER
K942546 · DXN
Dynatech/Nevada, Inc.
Cardiovascular · 241d
Cleared Jan 27, 1995
SORIN BLOOD CARDIOPLEGIA CONSOLE
K942582 · DTQ
Sorin Biomedical, Inc.
Cardiovascular · 240d
Cleared Jan 27, 1995
TRIMLINE 2000
K943081 · DXN
Pymah Corp.
Cardiovascular · 213d
Cleared Jan 24, 1995
K-DEFIB/PACE PEDIATRIC ELECTRODE
K934692 · MKJ
Katecho, Inc.
Cardiovascular · 481d
Cleared Jan 24, 1995
WARM AIR WARMING UNIT
K942599 · DWJ
Cincinnati Sub-Zero Products, Inc.
Cardiovascular · 237d
Cleared Jan 24, 1995
DIGITAL HOLTER RECORDER
K942781 · DSH
Agilent Technologies
Cardiovascular · 225d
Cleared Jan 24, 1995
WARM AIR HYPERTHEERMIA SYSTEM (MODELS #130 AND #133)
K942790 · DWJ
Cincinnati Sub-Zero Products, Inc.
Cardiovascular · 225d
Cleared Jan 18, 1995
HEARTPRINT
K942862 · DSH
Medata, Inc.
Cardiovascular · 215d
Cleared Jan 17, 1995
QUEST CORONARY SINUS PERFUSION CANNULA
K941166 · DWF
Quest Medical, Inc.
Cardiovascular · 312d
Cleared Jan 17, 1995
KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM
K942664 · JOW
The Kendal Co.
Cardiovascular · 225d
Cleared Jan 13, 1995
SCIMED(R) CORONARY GUIDE WIRE EXCHANGE/INFUSION CATHETER
K945593 · KRA
Scimed Life Systems, Inc.
Cardiovascular · 60d
Cleared Jan 11, 1995
HEART 1001
K931020 · DXH
Aerotel, Ltd.
Cardiovascular · 684d
Cleared Jan 06, 1995
HORIZON 9000 WS
K940415 · DXG
Mennen Medical, Inc.
Cardiovascular · 343d
Cleared Jan 05, 1995
BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS
K944858 · DSY
Baxter Edwards
Cardiovascular · 94d
Cleared Jan 04, 1995
IDEAS OCCLUDER
K935964 · DXC
Ideas For Medicine, Inc.
Cardiovascular · 387d
Cleared Jan 04, 1995
ANGIOMAT 3000, 6000, CT INJECTOR
K944875 · DXT
Lievel-Flarsheim Co.
Cardiovascular · 93d
Cleared Jan 03, 1995
ELECTROPHYSIOLOGY SYSTEMS, INC. EP-EASY
K935186 · DQK
Electrophysiology Systems, Inc.
Cardiovascular · 434d
Cleared Dec 30, 1994
DATEX AS/3 PATIENT MONITOR
K933156 · DPS
Datex Division Instrumentarium Corp.
Cardiovascular · 549d
Cleared Dec 30, 1994
THERA-FLOW GRADIENT SEQUENTIAL PUMP
K943392 · JOW
Meds Systems, Inc.
Cardiovascular · 169d
Cleared Dec 30, 1994
SCIMED PURSUIT EXCHANGE PTCA GUIDE WIRE
K945159 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 70d
Cleared Dec 28, 1994
STAT PADZ STERILE ADULT MULTI-FUNCTION ELECTRODES
K943698 · MKJ
Zoll Medical Corp
Cardiovascular · 152d
Cleared Dec 27, 1994
DAIG DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER
K942379 · DRF
Daig Corp.
Cardiovascular · 232d